Diffuse Large B-cell Lymphoma
Conditions
Keywords
Diffuse large B-cell Lymphoma, R-IPI
Brief summary
The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.
Detailed description
The main aim of this study is to compare the prognostic value of R-IPI at diagnosis and relapse, relating it with the obtained response after second line
Interventions
None listed
Sponsors
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 \> years old * Patients with refractory/relapsed diffuse large B-cell lymphoma after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab * Ability to understand and willingness to sign a written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R-IPI Index (Revised International Prognostic Index) | At diagnoses | Data will be recorded from diagnosis to second line response, an expected average of 7 months |
| Predictive Value of R-IPI at Diagnosis | At diagnosis | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| p-53 Expression | At diagnosis | immunohistochemical reaction of cells with p-53 antibody |
| p53 Expression | At the beginning of the 2nd line of treatment | immunohistochemical reaction of cells with p-53 antibody |
| Multiple Myeloma Oncogene 1 (MUM-1) Expression | At diagnosis | immunohistochemical reaction of cells with MUM-1 antibody |
| MUM-1 Expression | At the beginning of the 2nd line of treatment | immunohistochemical reaction of cells with MUM-1 antibody |
| Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status | At the beginning of the 2nd line of treatment | ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus |
| Ann Arbor Staging | At the beginning of the 2nd line of treatment | Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition |
| Bcl-2 Expression | At diagnosis | immunohistochemical reaction of cells with Bcl-2 antibody |
| Response to Second Line of Treatment | After second line of treatment | Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment. |
| Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | At diagnosis | Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse |
| Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | At diagnosis | Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse |
| Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | At diagnosis | Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse |
| Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | At diagnosis | Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse |
| Response to First Line of Treatment | After first line treatment | Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment. |
| Bcl-6 Expression | At diagnosis | immunohistochemical reaction of cells with Bcl-6 antibody |
Countries
Spain
Participant flow
Recruitment details
Recruitment was carried out between April 2009 and January 2011 in Hematology Departments of 56 Spanish Hospitals
Participants by arm
| Arm | Count |
|---|---|
| Refractory/Relapsed LDCBG patients with refractory/relapsed diffuse large B-cell lymphoma | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 12 |
Baseline characteristics
| Characteristic | Refractory/Relapsed LDCBG |
|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 14.1 |
| Ann Arbor Staging I | 6 participants |
| Ann Arbor Staging II | 20 participants |
| Ann Arbor Staging III | 37 participants |
| Ann Arbor Staging IV | 83 participants |
| ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 0 | 48 participants |
| ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 1 | 55 participants |
| ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 2 | 25 participants |
| ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 3 | 15 participants |
| ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 4 | 3 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 146 |
| serious Total, serious adverse events | 18 / 146 |
Outcome results
Primary
Predictive Value of R-IPI at Diagnosis
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Predictive Value of R-IPI at Diagnosis | Global response to 2nd line + very good prognos | 4 participants |
| Refractory/Relapsed LDCBG | Predictive Value of R-IPI at Diagnosis | No global response to 2nd line + very good prognos | 1 participants |
| Refractory/Relapsed LDCBG | Predictive Value of R-IPI at Diagnosis | Global response to 2nd line + good prognosis | 28 participants |
| Refractory/Relapsed LDCBG | Predictive Value of R-IPI at Diagnosis | No global response to 2nd line + good prognosis | 19 participants |
| Refractory/Relapsed LDCBG | Predictive Value of R-IPI at Diagnosis | Global response to 2nd line + poor prognosis | 56 participants |
| Refractory/Relapsed LDCBG | Predictive Value of R-IPI at Diagnosis | No global response to 2nd line + poor prognosis | 37 participants |
p-value: 0.812Fisher Exact
Primary
R-IPI Index (Revised International Prognostic Index)
Data will be recorded from diagnosis to second line response, an expected average of 7 months
Time frame: At diagnoses
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | R-IPI Index (Revised International Prognostic Index) | Very good prognosis (0) | 3.4 percentage of participants |
| Refractory/Relapsed LDCBG | R-IPI Index (Revised International Prognostic Index) | Good prognosis (1,2) | 32.2 percentage of participants |
| Refractory/Relapsed LDCBG | R-IPI Index (Revised International Prognostic Index) | Poor prognosis (3,4,5) | 64.4 percentage of participants |
Primary
R-IPI Index (Revised International Prognostic Index)
The IPI is based on the evaluation of 5 clinical factors: age \> 60 years Ann Arbor stage III or IV disease \> 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) \_ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.
Time frame: At the beginning of the 2nd line of treatment, an average of 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | R-IPI Index (Revised International Prognostic Index) | Very good prognosis (0) | 9.6 percentage of patients |
| Refractory/Relapsed LDCBG | R-IPI Index (Revised International Prognostic Index) | Good prognosis (1,2) | 47.3 percentage of patients |
| Refractory/Relapsed LDCBG | R-IPI Index (Revised International Prognostic Index) | Poor prognosis (3,4,5) | 43.2 percentage of patients |
Secondary
Ann Arbor Staging
Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
Time frame: At the beginning of the 2nd line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Ann Arbor Staging | II | 21.9 percentage of patients |
| Refractory/Relapsed LDCBG | Ann Arbor Staging | III | 19.9 percentage of patients |
| Refractory/Relapsed LDCBG | Ann Arbor Staging | IV | 45.9 percentage of patients |
| Refractory/Relapsed LDCBG | Ann Arbor Staging | I | 12.3 percentage of patients |
Secondary
Bcl-2 Expression
immunohistochemical reaction of cells with Bcl-2 antibody
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Bcl-2 Expression | Positive | 54.1 percentage of participants |
| Refractory/Relapsed LDCBG | Bcl-2 Expression | Negative | 8.9 percentage of participants |
| Refractory/Relapsed LDCBG | Bcl-2 Expression | Not available | 37.0 percentage of participants |
Secondary
Bcl-2 Expression
immunohistochemical reaction of cells with Bcl-2 antibody
Time frame: At the beginning of the 2nd line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Bcl-2 Expression | Positive | 30 participants |
| Refractory/Relapsed LDCBG | Bcl-2 Expression | Negative | 5 participants |
| Refractory/Relapsed LDCBG | Bcl-2 Expression | Not Available | 111 participants |
Secondary
Bcl-6 Expression
immunohistochemical reaction of cells with Bcl-6 antibody
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Bcl-6 Expression | Negative | 20 participants |
| Refractory/Relapsed LDCBG | Bcl-6 Expression | Not available | 63 participants |
| Refractory/Relapsed LDCBG | Bcl-6 Expression | Positive | 63 participants |
Secondary
Bcl-6 Expression
immunohistochemical reaction of cells with Bcl-6 antibody
Time frame: At the beginning of the second line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Bcl-6 Expression | Positive | 14.4 percentage of participants |
| Refractory/Relapsed LDCBG | Bcl-6 Expression | Negative | 7.5 percentage of participants |
| Refractory/Relapsed LDCBG | Bcl-6 Expression | Not available | 78.1 percentage of participants |
Secondary
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus
Time frame: At the beginning of the 2nd line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status | ECOG 0 | 56 participants |
| Refractory/Relapsed LDCBG | Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status | ECOG 1 | 54 participants |
| Refractory/Relapsed LDCBG | Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status | ECOG 2 | 22 participants |
| Refractory/Relapsed LDCBG | Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status | ECOG 3 | 12 participants |
| Refractory/Relapsed LDCBG | Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status | ECOG 4 | 2 participants |
Secondary
Multiple Myeloma Oncogene 1 (MUM-1) Expression
immunohistochemical reaction of cells with MUM-1 antibody
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Multiple Myeloma Oncogene 1 (MUM-1) Expression | Positive | 16.4 percentage of participants |
| Refractory/Relapsed LDCBG | Multiple Myeloma Oncogene 1 (MUM-1) Expression | Negative | 10.3 percentage of participants |
| Refractory/Relapsed LDCBG | Multiple Myeloma Oncogene 1 (MUM-1) Expression | Not available | 73.3 percentage of participants |
Secondary
MUM-1 Expression
immunohistochemical reaction of cells with MUM-1 antibody
Time frame: At the beginning of the 2nd line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | MUM-1 Expression | Positive | 5.5 percentage of participants |
| Refractory/Relapsed LDCBG | MUM-1 Expression | Negative | 5.5 percentage of participants |
| Refractory/Relapsed LDCBG | MUM-1 Expression | Not available | 89.0 percentage of participants |
Secondary
p-53 Expression
immunohistochemical reaction of cells with p-53 antibody
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | p-53 Expression | Positive | 12.3 percentage of participants |
| Refractory/Relapsed LDCBG | p-53 Expression | Negative | 10.3 percentage of participants |
| Refractory/Relapsed LDCBG | p-53 Expression | Not available | 77.4 percentage of participants |
Secondary
p53 Expression
immunohistochemical reaction of cells with p-53 antibody
Time frame: At the beginning of the 2nd line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | p53 Expression | Positive | 5.5 percentage of participants |
| Refractory/Relapsed LDCBG | p53 Expression | Negative | 4.8 percentage of participants |
| Refractory/Relapsed LDCBG | p53 Expression | Not available | 89.7 percentage of participants |
Secondary
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | Global response to 2nd line + Bcl-6 + | 34 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | Global response to 2nd line + Bcl-6 - | 14 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | Global response to 2nd line + Blc-6 ND | 40 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | No global response to 2nd line + Bcl-6 + | 28 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | No global response to 2nd line + Bcl-6 - | 6 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis | No global response to 2nd line + Bcl-6 ND | 23 participants |
p-value: 0.402Chi-squared
Secondary
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | Global response to 2nd line + MUM1 + | 17 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | Global response to 2nd line + MUM1 - | 6 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | No global response to 2nd line + MUM1 + | 7 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | No global response to 2nd line + MUM1 - | 8 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | Global response to 2nd line + MUM1 ND | 65 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis | No global response to 2nd line + MUM1 ND | 42 participants |
p-value: 0.234Chi-squared
Secondary
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | Global response to 2nd line + p53+ | 13 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | Global response to 2nd line + p53- | 8 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | No global response to 2nd line + p53+ | 5 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | No global response to 2nd line + p53- | 6 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | Global response to 2nd line + p53 ND | 67 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis | Global response to 2nd line + p53 - ND | 46 participants |
p-value: 0.557Chi-squared
Secondary
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | Global response to 2nd line + Bcl-2 + | 50 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | Global response to 2nd line + Bcl-2 - | 8 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | No global response to 2nd line + Bcl-2 + | 28 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | Global response to 2nd line +Bcl-2 ND | 30 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | No global response to 2nd line + Bcl-2 ND | 24 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis | No global response to 2nd line + Bcl-2 - | 5 participants |
p-value: 0.612Chi-squared
Secondary
Response to First Line of Treatment
Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.
Time frame: After first line treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Response to First Line of Treatment | Complete response | 58 participants |
| Refractory/Relapsed LDCBG | Response to First Line of Treatment | Partial response | 52 participants |
| Refractory/Relapsed LDCBG | Response to First Line of Treatment | Stable disease | 10 participants |
| Refractory/Relapsed LDCBG | Response to First Line of Treatment | Progressive disease | 21 participants |
| Refractory/Relapsed LDCBG | Response to First Line of Treatment | Uncertain complete response | 5 participants |
Secondary
Response to Second Line of Treatment
Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.
Time frame: After second line of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Response to Second Line of Treatment | Complete response | 46 participants |
| Refractory/Relapsed LDCBG | Response to Second Line of Treatment | Uncertain complete response | 15 participants |
| Refractory/Relapsed LDCBG | Response to Second Line of Treatment | Partial response | 27 participants |
| Refractory/Relapsed LDCBG | Response to Second Line of Treatment | Stable disease | 9 participants |
| Refractory/Relapsed LDCBG | Response to Second Line of Treatment | Progressive disease | 38 participants |
| Refractory/Relapsed LDCBG | Response to Second Line of Treatment | Not evaluated | 10 participants |
Post Hoc
Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At relapse
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse | Global response to 2nd line + lymphocyte <1 | 40 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse | Global response to 2nd line + lymphocyte >=1 | 47 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse | No global response to 2nd line + lymphocyte <1 | 35 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse | No global response to 2nd line + lymphocyte >=1 | 20 participants |
p-value: 0.057Fisher Exact
Post Hoc
Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At relapse
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse | Global response to 2nd line | 2.47 mg/100ml | Standard Deviation 1.51 |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse | No global response to 2nd line | 2.41 mg/100ml | Standard Deviation 1.51 |
Post Hoc
Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At relapse
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse | Global response to 2nd line + ratio <=2.6 | 46 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse | Global response to 2nd line + ratio >2.6 | 40 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse | No global response to 2nd line + ratio <=2.6 | 37 participants |
| Refractory/Relapsed LDCBG | Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse | No global response to 2nd line + ratio >2.6 | 18 participants |
p-value: 0.117Fisher Exact